Out-of-Hospital Cardiac ArrestSWALSNCT03041350
Smartphone Video-assisted Advanced Life Support of Patients With Out-of-hospital Cardiac Arrest by EMS Under Physician Direction
A study testing Smartphone video-assisted ALS(advanced life support) in people with Out-of-Hospital Cardiac Arrest, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Direct medical control using video conferencing capabilities of smartphones has never been conducted in out-of-hospital cardiac arrest patients. This study was conducted to investigate its feasibility and treatment effectiveness in out-of-hospital cardiac arrest (OHCA) patients using a real-time smartphone video call. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Out-of-Hospital Cardiac Arrest
- What is being tested?
- Smartphone video-assisted ALS(advanced life support)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all EMS-treated OHCA patients older than 18 years transported to the hospital unless otherwise diagnosed with trauma, poisoning, asphyxia, hanging, or any other non-disease-origin factors.
Who cannot join
- Patients with do-not-resuscitate (DNR) orders and with obvious signs of irreversible death, including rigor mortis and corruption
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Emergency medical service system of Suwon city
Suwon, Gyeonggi-do
About this study
Direct medical control using video conferencing capabilities of smartphones has never been conducted in out-of-hospital cardiac arrest patients. This study was conducted to investigate its feasibility and treatment effectiveness in out-of-hospital cardiac arrest (OHCA) patients using a real-time smartphone video call.
Read the detailed description
If cardiac arrest is suspected, the EMS personnel contacted the medical director before arriving at the scene. Upon the arrival at the scene of the two activated paramedic teams, they rapidly switch to ALS under teamwork-based BLS and video medical control. Using this video medical control, high-quality CPR, cardiac arrest rhythm confirmation, defibrillation, proper drug administration instructions, advanced airway insertion, etc. are performed. The medical director then decides on patient transfer if the asystole and pulseless electrical activity findings are persistent even after more than 20-minutes of ALS. After initiating the transfer, the medical director contacts the hospital where the patient is to be transferred to after completing the video medical control. The medical director provides an explanation of the treatment to the caregiver via video. After returning to the fire station, the EMS personnel who had completed the patient's transfer the enters the information by hand on the separate form, takes a picture of the document, and uploads it to SNS within 24 hours. Through this information shared via SNS, the research staff the provides a direct feedback to the EMS personnel, and further discussion performed within the SNS. All the incident cases of OHCA during the before and during interventional periods were registered using an EMS run sheet for basic ambulance operation information, the EMS cardiac arrest registry for the Utstein factors, and the OHCA registry for the hospital care and survival outcomes. The EMS run sheet and EMS cardiac arrest registry were collected by the EMS providers. The medical records for hospital care and outcomes were abstracted by the trained reviewer for this study
- Conditions
- Out-of-Hospital Cardiac Arrest
- Being tested
- Smartphone video-assisted ALS(advanced life support)
- Keywords
- Emergency Medical Services, Smartphone, Survival
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone video-assisted ALS(advanced life support)Other
As an preparation for this study, personnel training in mock advanced life support (ALS) simulation including the smartphone video call methodology was conducted. The smartphones were not separately purchased or produced; commercially available smartphones already owned by the emergency medical service (EMS) personnel and medical directors were used. To facilitate the smartphone video call between the medical director and the EMS personnel and to prevent the caregivers or others nearby from hearing the conversation, Bluetooth earphone sets were used. Data were collected using the cardiopulmonary resuscitation (CPR) recording form uploaded in SNS which consisted of EMS personnel and medical directors, and the quality of CPR was evaluated
| Study group | Role | What they receive |
|---|---|---|
| Smartphone video-assisted ALS & Conventional CPR | Experimental | In study period, using this video medical control, high-quality CPR, cardiac arrest rhythm confirmation, defibrillation, proper drug administration instructions, advanced airway insertion, etc. are performed. The medical director then decides on patient transfer if the asystole and pulseless electrical activity findings are persistent even after more than 20-minutes of ALS.
The conventional CPR is Basic life support only in the automatic external defibrillator (AED) mode 5-10 minutes at the scene, are not allowed to stop resuscitation at the scene unless there is a return of spontaneous circulation (ROSC) or pre-hospital cardiac arrest patient has already been transported to a hospital. Receives: Other: Smartphone video-assisted ALS(advanced life support) |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Measured: 1 year
favorable neurologic outcome rate
Measured: 1 year
Secondary outcomes (1)
rate of prehospital return of systemic circulation(ROSC)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study startJan 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Public Safety and Security, Ajou University School of Medicine, Saint Vincent's Hospital, Korea, Soonchunhyang University Hospital
- Responsible party
- Principal investigator, Yu Jin Kim, MD, Seoul National University Hospital
- Investigators
- Gi Woon Kim, M.D., Ph.D., Principal investigator, Department of Emergency Medicine, Soonchunhyang University Bucheon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041350
- Sponsor's protocol ID
- SWALS
- Acronym
- SWALS
- Status last verified
- Jan 2017
- First submitted
- 11 Dec 2016
- Last updated
- 2 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Video-assisted Advanced Life Support of Patients With Out-of-hospital Cardiac Arrest by EMS Under Physician Direction
- ClinicalTrials.gov ID
- NCT03041350
- Acronym / sponsor ID
- SWALS / SWALS
- Conditions
- Out-of-Hospital Cardiac Arrest
- Keywords
- Emergency Medical Services, Smartphone, Survival
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Public Safety and Security, Ajou University School of Medicine, Saint Vincent's Hospital, Korea, Soonchunhyang University Hospital
- Study start
- Jan 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Direct medical control using video conferencing capabilities of smartphones has never been conducted in out-of-hospital cardiac arrest patients. This study was conducted to investigate its feasibility and treatment effectiveness in out-of-hospital cardiac arrest (OHCA) patients using a real-time smartphone video call.
Detailed description
If cardiac arrest is suspected, the EMS personnel contacted the medical director before arriving at the scene. Upon the arrival at the scene of the two activated paramedic teams, they rapidly switch to ALS under teamwork-based BLS and video medical control. Using this video medical control, high-quality CPR, cardiac arrest rhythm confirmation, defibrillation, proper drug administration instructions, advanced airway insertion, etc. are performed. The medical director then decides on patient transfer if the asystole and pulseless electrical activity findings are persistent even after more than 20-minutes of ALS. After initiating the transfer, the medical director contacts the hospital where the patient is to be transferred to after completing the video medical control. The medical director provides an explanation of the treatment to the caregiver via video. After returning to the fire station, the EMS personnel who had completed the patient's transfer the enters the information by hand on the separate form, takes a picture of the document, and uploads it to SNS within 24 hours. Through this information shared via SNS, the research staff the provides a direct feedback to the EMS personnel, and further discussion performed within the SNS. All the incident cases of OHCA during the before and during interventional periods were registered using an EMS run sheet for basic ambulance operation information, the EMS cardiac arrest registry for the Utstein factors, and the OHCA registry for the hospital care and survival outcomes. The EMS run sheet and EMS cardiac arrest registry were collected by the EMS providers. The medical records for hospital care and outcomes were abstracted by the trained reviewer for this study
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smartphone video-assisted ALS & Conventional CPR | Experimental | Other: Smartphone video-assisted ALS(advanced life support)In study period, using this video medical control, high-quality CPR, cardiac arrest rhythm confirmation, defibrillation, proper drug administration instructions, advanced airway insertion, etc. are performed. The medical director then decides on patient transfer if the asystole and pulseless electrical activity findings are persistent even after more than 20-minutes of ALS. The conventional CPR is Basic life support only in the automatic external defibrillator (AED) mode 5-10 minutes at the scene, are not allowed to stop resuscitation at the scene unless there is a return of spontaneous circulation (ROSC) or pre-hospital cardiac arrest patient has already been transported to a hospital. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all EMS-treated OHCA patients older than 18 years transported to the hospital unless otherwise diagnosed with trauma, poisoning, asphyxia, hanging, or any other non-disease-origin factors.
Key exclusion criteria (1 listed)
- Patients with do-not-resuscitate (DNR) orders and with obvious signs of irreversible death, including rigor mortis and corruption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone video-assisted ALS(advanced life support)As an preparation for this study, personnel training in mock advanced life support (ALS) simulation including the smartphone video call methodology was conducted. The smartphones were not separately purchased or produced; commercially available smartphones already owned by the emergency medical service (EMS) personnel and medical directors were used. To facilitate the smartphone video call between the medical director and the EMS personnel and to prevent the caregivers or others nearby from hearing the conversation, Bluetooth earphone sets were used. Data were collected using the cardiopulmonary resuscitation (CPR) recording form uploaded in SNS which consisted of EMS personnel and medical directors, and the quality of CPR was evaluated | Other | Smartphone video-assisted ALS & Conventional CPR |
Primary outcome
survival rate
Time frame: 1 year
favorable neurologic outcome rate
Time frame: 1 year
1 secondary outcome
rate of prehospital return of systemic circulation(ROSC)
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gi Woon Kim, M.D., Ph.D. principal investigator
Department of Emergency Medicine, Soonchunhyang University Bucheon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone video-assisted ALS(advanced life support) in people with Out-of-Hospital Cardiac Arrest, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival rate (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2017.